BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 11111086 · Received January 4, 2021

    Report

    Report Number
    0001825034-2020-04464
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 4, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLIED PHOTO WAS ENLARGED AND ON THE HEAD YOU CAN SEE 072330, +9MM, B AND BLOOD OBSCURES ANY OTHER INFORMATION. ALSO, A DAMAGED LINER WITH NO VISIBLE INFORMATION AND A LOCKING RING WITH NO VISIBLE INFORMATION CAN BE SEEN. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. ITEM# UNK STEM LOT# UNK- PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MMI REVIEW IDENTIFIED OSTEOLYSIS, NO ACUTE FRACTURE, DISLOCATION, OR FRANK IMPLANT LOOSENING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. X-RAY REVIEW IDENTIFIED IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 04463.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION 11 YEAR AFTER IMPLANTATION DUE TO CORROSION AT HEAD NECK JUNCTION. HEAD AND LINER WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8383 UNKNOWN STEM PROSTHETIC, HIP KWY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ITEM#00630505636 NAME LINER STD 3.5 MM LOT#UNK